Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-PanTumor01)
Summary
This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts. The primary purpose of the parts are: * Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of ifinatamab deruxtecan (I-DXd). * Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent. This study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant is off the study. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: * they withdraw * their disease gets worse * they experience unacceptable side effects.
Arms & interventions
- DrugIfinatamab deruxtecan (I-DXd)
A total anti-B7H3 antibody and MAAA-1181a
Outcome measures
Primary
Evaluate the incidence of dose-limiting toxicities (DLTs)
Time frame: Day 1 to Day 21 in Cycle 1 in the dose escalation part
Evaluate the incidence of adverse events (AEs)
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Investigate the antitumor activity of ifinatamab deruxtecan (I-DXd)
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Secondary
Characterize the PK parameter AUClast
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter AUCtau
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter Cmax
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter Tmax
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter Ctrough
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Assess the incidence of anti-drug antibodies (ADAs)
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Eligibility criteria
Study locations (15)
Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Florida Cancer Specialists
Orlando, Florida, 32804
Florida Cancer Specialists
Sarasota, Florida, 34232
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Henry Ford Hospital
Detroit, Michigan, 48202
Washington University
St Louis, Missouri, 63110
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Columbia University Medical Center
New York, New York, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
The Ohio State University
Columbus, Ohio, 43210
Sidney Kimmel Cancer Center - Thomas Jefferson
Philadelphia, Pennsylvania, 19107
SCRI Oncology Partners
Nashville, Tennessee, 37203
Tennessee Oncology
Nashville, Tennessee, 37203
MDACC (MD Anderson Cancer Center)
Houston, Texas, 77030
References
- Johnson ML, Patel MR, Falchook GS, Koyama T, Gutierrez M, Awad MM, Piha-Paul SA, Friedman CF, Satoh T, Okamoto N, Singh J, Yoshizuka N, Windish HP, Qian M, Tran BP, Doi T. Ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate, in patients with advanced solid tumours (IDeate-PanTumor01): dose-escalation results from a phase 1/2 trial. Lancet Oncol. 2026 Apr;27(4):491-501. doi: 10.1016/S1470-2045(25)00733-8.(PubMed)